Collagenous Colitis MedDRA version: 20.0 Level: LLT Classification code 10048928 Term: Colitis collagenous System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Xifaxan
Product Name: Xifaxan
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIFAXIMIN
CAS Number: 80621-81-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
XiCoCo study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age >18 years • Written informed consent • Histological findings fulfill criteria for CC: o A thickenened subepithelial collagenous band >10 µm in veloriented colonic biopsies and o Increased count of inflammatory cells in lamina propria • Diagnostic biopsies are a maximum of two years old • A history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed CC or a history of clinical relapse for more than a week in patients with known CC • Active disease: > 3 stools/day or >1 watery stool/day measured as a mean during a week prior to baseline Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: - Significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps 2,5 x upper limit), cirrhosis or portal hypertension - Pregnancy or lactation (assured by negative P-hCG at inclusion) - History of significant intestinal resection - Treatment with 5-ASA, Salazopyrin, immunomudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), systemic or rectal administered glucocorticoids (except for Budesonide) within the last three month - Allergy or intolerance to Rifaximin (or similar antibiotics such as Rifampicin or Rifabutin) - Expectation of lack of cooperation or insufficient comprehension - Concomitant participation in an other clinical trial or participation within the last 30 days - Patients receiving Warfarin or Marcoumar (interaction with risk of uncontrolled INR-levels)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess if 4 weeks treatment with Rifaximin as a supplement to a standard course of Budesonide against active Collagenous Colitis can reduce the risk of relapse after treatment cessation.;Secondary Objective: The number of patients in clinical remission 12 weeks after cessation of Budesonide in the Rifaximin group compared to the placebo group. Remission defined as < 3 daily bowel movements or < 1 watery stool per day measured as a mean during the last week. Reduction in MCDAI score from baseline to week 18. Time to relapse. Quality of life assessed by short health scale (SHS) 12 weeks after completed Budesonide-course. Number of patients in histolocigal remission 12 weeks after cessation of treatment. Changes is gut microbiome measured by 16SrDNA-analysis on stool samples. Proportion of patients in clinical remission and difference in quality of life 6 and 12 month after treatment cessation. ;Primary end point(s): The number of patients in clinical remission 12 weeks after cessation of Budesonide in the Rifaximin group compared to the placebo group;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduction in MCDAI score from baseline to week 18. Time to relapse. Quality of life assessed by short health scale (SHS) 12 weeks after completed Budesonide-course. Number of patients in histolocigal remission 12 weeks after cessation of treatment. Changes is gut microbiome measured by 16SrDNA-analysis on stool samples. Proportion of patients in clinical remission and difference in quality of life 6 and 12 month after treatment cessation. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Denmark
Contacts
Public ContactDiagnostic Center
XiCoCo study group
Outcome results
None listed